JP4508866B2 - Vascular closure clip and delivery device - Google Patents

Abstract

A medical device including a shape-memory metallic body comprising a plurality of closed cells with a plurality of terminal cell ends and a plurality of tissue engaging members extending from the shape-memory metallic body, a shaft of each tissue engaging member extending from the terminal cell end at least approximately in a direction of the long axis of the closed cell in an expanded configuration.

Description

  The present invention relates to a clip for closing a puncture hole made in a blood vessel and a device for closing the puncture hole using such a clip.

  Many medical diagnosis and intervention procedures (intervention procedures) use long catheters that are placed in the human vasculature. These catheters are routed along the guidewire and positioned in the heart for heart treatment and placed in the brain for nerve treatment. The entrance site is usually a puncture hole provided in the femoral artery of the patient's groin. Once this procedure is complete, the catheter and guidewire must be removed and the puncture hole must be closed to prevent excessive bleeding and eliminate the risk of infection. Traditionally, the puncture hole is maintained with manual pressure on the puncture site until hemostasis occurs around the puncture hole, or a sand bag is placed in the groin area near the puncture hole. The patient was closed by keeping it stationary until hemostasis occurred.

  In recent years, many medical devices have been developed and put on the market for the purpose of closing the puncture hole. These medical devices are broadly divided into two categories: (a) mechanical closure devices that mechanically close the puncture hole using, for example, sutures or staples, and (b) occlusion devices such as collagen plugs and gels. The Examples of the prior art in this technical field include US Pat. No. 5,860,991 (Patent Document 1) and US Pat. No. 6,322,580 (Patent Document 2).

  U.S. Pat. No. 5,860,991 describes a device for closing a puncture hole using a suture. This device is introduced over the guidewire and into the artery, and finally a blood signal appears at the proximal end, thereby indicating that the correct position has been achieved. At this point, the internal anchor is deployed and the needle is advanced from the exterior of the artery through the artery wall and into the anchor component to grasp the ends of the suture loop. The needle is then placed back into the instrument and the instrument is removed from the artery, leaving behind the open end of the suture outside the patient's skin. A knot is made and lowered along the suture, thereby closing the loop around the puncture hole and closing the puncture hole. Next, the suture is cut using a cutting instrument.

  A problem associated with this device is that it requires a significant number of steps in its use, and tying a suture loop requires a suturing action around the puncture hole, which can cause an accidental suture. May break in the middle of the hole and pushing the needle from the outside to the inside of the artery will create two more puncture holes, and eventually the suture loop will remain in the artery There is a risk of dropping the plaque in the artery.

  Another example of a mechanical closure device is described in US Pat. No. 6,322,580, which uses metal staples to close the puncture hole. ing. This mechanical closure device requires the use of a dedicated dilator and sheath, which is guided over the guide wire along the femoral artery. Once the guidewire is removed, the internal ballast is activated and retracted and applied to the inner wall of the artery. The sheath dilator is then removed and the stapler instrument is advanced through the sheath to deploy the staples in the arterial wall. The stapler is then removed, the stabilizer is deactivated, and the introducer sheath is removed from the tissue tract.

  A problem associated with this mechanical closure device is that a dedicated sheath is used that must be inserted over the guidewire and advanced into the tissue tract before the closure procedure is performed. In addition, a sophisticated ballast-type instrument must be deployed in the artery before the stapler can be sent to close the puncture hole. Once the staples have been sent, the stapler device can be removed from the sheath, and then the internal stabilizer can be folded and retracted through the puncture hole into the sheath, after which the sheath itself can be removed from the tissue tract.

US Pat. No. 5,860,991 US Pat. No. 6,322,580

  Both devices described above are effective in closing the puncture hole, but these devices are inherently mechanically complex from an operational point of view. In addition, this procedure requires a significant number of steps. End users of such devices are more accustomed to catheter utilization techniques delivered along a guidewire combined with balloon inflation and deflation. Accordingly, there is a need for an improved puncture closure device that operates in a manner consistent with catheter-utilizing devices, such as angiographic and angioplasty catheters. In addition, it is necessary to reduce the complexity of such closure devices by reducing the number of components and steps required in this procedure.

Accordingly, the present invention provides a clip for closing a puncture hole of a blood vessel, comprising a ring having an elastically expandable periphery and a plurality of barbed branches extending at least in substantially the same direction from one edge of the ring. Provided is a clip characterized by having.
The ring may be circular or any suitable closed loop shape.

  The present invention further provides an apparatus for closing a puncture hole in a blood vessel using a clip of the type described above, comprising an elongate body having a front end that can be inserted into the blood vessel through the puncture hole, and a rear of the front end. A clip dilator fitted to the body, wherein the dilator is adapted to receive the clip with its ring surrounding the dilator and its branches protruding toward the front end of the body. The clip expander is operable to elastically expand around the ring, and the clip can move forward in its expanded state so that the branch punctures the tissue around the hole, and then The clip expander provides an apparatus that is operable to release the clip and allow the body and clip expander to be removed from the ring.

  In one embodiment, a clip referred to herein as a “ring occluder” is fitted into a deflated balloon, which is coupled to the shaft of a plastic catheter. By inflating the balloon, an outward expansion force is applied under the ring occluder, thereby expanding the ring occluder to a diameter equal to the fully expanded diameter of the balloon in which it is fitted. A barbed leg extends from one edge of the occluder ring over a distance of 3-5 mm. The catheter has three lumens, one becomes the channel for the liquid that inflates the balloon, one is the channel for blood, and the third is the channel that houses the guide wire.

  For clinical use, a catheter is fitted into a guide wire and is routed over the guide wire along the tissue tract and into the blood vessel. The catheter is advanced until the blood signal finally appears at the blood return port. This shows that the blood vessel inlet port is now located within the blood vessel. The catheter is then withdrawn until blood flow stops, so that it can be seen that the blood inlet port is now located within the puncture hole and the ring occluder is located a predetermined distance from the vessel wall. Next, the guide wire is removed. Next, saline is used to inflate the balloon, thereby increasing the diameter of the ring occluder and expanding the ring occluder outward into the tissue tract. The diameter of the balloon on the posterior side of the ring occluder is increased to form a shoulder or edge that advances the ring occluder forward. Once fully expanded, the catheter is pushed forward so that the barbed leg of the ring occluder punctures the surrounding tissue and arterial wall near the puncture hole. The catheter continues to advance and eventually encounters a considerable amount of resistance to the front. This tells the user that the barbed leg has now been positioned within the artery wall and the catheter should no longer be advanced any further. The inflated balloon is then deflated, the guide wire is removed from the catheter, and the catheter is removed from the tissue tract. Upon removal of the catheter, the rebounding force of the ring occluder pulls the edges of the puncture holes together, thereby sealing the holes in a closed state.

In another embodiment, a sliding collar is used in place of the balloon, and the sliding collar has splines that are pushed outward to deform the ring occluder.
The advantage of such devices is that they are considerably easier to operate than the mechanical closure devices described above. In addition, the mode of operation of the balloon-type instrument, with the balloon inflated from the external port, provides a catheter that is routed over the guidewire and along with the interventional radiologist and Consistent with the operating mode of other devices used by cardiologists.

Embodiments of the present invention will now be described by way of example with reference to the accompanying drawings.
First, referring to FIG. 1, a ring occluder 10 that closes a puncture hole of a blood vessel is composed of a metal ring 12 that is continuous in the circumferential direction. The circumference of the ring 12 is sinusoidal, and the ring has a plurality of pointed metal branches 14 extending from one edge of the ring 12 (the lower edge in FIG. 1) in at least approximately the same direction. is doing. The branch portions have a length of 3 to 5 mm and extend from the sine-shaped alternately located minimum portions. The branch 14 is barbed, which means in the present invention that the branch is shaped to resist retraction once it has penetrated the tissue. The branches 14 preferably converge slightly toward the central axis of the ring 12. FIG. 1 (a) shows the ring occluder in its unexpanded state, and FIG. 1 (b) shows the ring occluder in its expanded state. In this case, the pitch between the sine-shaped peak portions is the circumference thereof. It increases in such a way as to provide a uniform expansion of the ring at all points above. The pitch between the barbed branches increases accordingly.

  FIG. 2A shows a ring occluder 10 'as a modified embodiment in its unexpanded state. In this case, the circumference of the ring 12 ′ is composed of a plurality of oval segments 16 each having a longitudinal central slit 18. The oval segments 16 are arranged side by side around the ring 12 with their longitudinal axes substantially parallel to each other. Each oval segment 16 is joined to the next segment by a narrow central constriction 20. As the ring expands as shown in FIG. 2 (b), the oval segment expands to a more rounded or open configuration, thus increasing the overall diameter of the ring 12 and the second oval segment. The pitch between barbed legs 14 extending from the base increases.

  In both cases, the material used to fabricate the ring occluder 10, 10 'is such that no permanent deformation of the metal occurs during the expansion of the occluder from the unexpanded state to the expanded state. The force exerted on the occluder is such that it remains within the elastic range of the material in which the occluder is used, thereby allowing the occluder to elastically return to its unexpanded state when the expansion force is removed. . Preferably, the diameter of the ring 12 may be elastically tripled, this diameter substantially returning to its original diameter when the expansion force is removed. An example of a suitable material for constructing the occluder is Nitinol or Memory Metal.

  3-5 show a first embodiment of the catheter delivery device with the ring occluder 10 in place (this catheter delivery device can also be used reasonably with the ring occluder 10 '). The catheter 22 is a flexible elongate plastic body with a longitudinal bore 24 (FIG. 5) that allows the catheter to slide along a pre-positioned guidewire 26. The forward end 28 of the catheter 22 tapers downward onto the guide wire 26, which guides the catheter through a hole 32 provided in the side wall of the blood vessel in position within the blood vessel 30 (FIG. 6). To do. A blood inlet port 34 is provided between the front end 28 and the ring occluder 10. Port 34 allows blood to enter another longitudinal bore 38 of catheter 22.

  An inflatable enclosure (“balloon”) 40 is positioned on the catheter 22 over about 5 cm to the back of the foremost tip 28 ′ of the front end 28. The balloon 40 coaxially surrounds the catheter, and in its deflated state, the balloon 40 is located in close contact with the catheter body. The ring occluder 10 is positioned on the balloon 40 closer to its forward end, and the ring 12 coaxially surrounds the balloon and catheter. A hub 42 is positioned at the posterior end of the catheter 22 and extends from the posterior end a blood port 44 coupled to a bore 38 in the catheter that is connected to the blood inlet port 34. Are combined. In addition, a balloon inflation port 46 is coupled to another longitudinal bore 48 provided in the catheter 22, which communicates with the interior of the balloon 40. A port 46 allows fluid (eg, saline) to be pumped into the balloon 40 under pressure to inflate the balloon 40 or withdraw the fluid in the balloon to return the balloon to its deflated state. .

  FIG. 4 is a view of the catheter delivery device near the ring occluder 10. The balloon 40 includes two axially adjacent regions 40a and 40b, so that when the balloon is inflated, these regions will have different diameters (FIG. 7). More specifically, when the balloon is inflated, the front area 40a where the occluder 10 is attached has a smaller diameter than the adjacent rear area 40b. The reason for this is that a shoulder 40c is provided behind the ring 12, and by pushing the catheter 22 as a whole in the forward direction, the ring occluder 10 is pushed forward into the tissue surrounding the puncture hole 32 with this shoulder. Is to be able to. Only the ring 22 is positioned on the balloon 40. The barbed branch 14 extends freely in the forward direction and slightly converges toward the catheter body. To prevent the region 40b from expanding at the expense of the region 40a when the balloon is inflated, the region 40b and the shoulder 40c are made of a thicker material than the region 40a.

  6-10 illustrate the catheter delivery device in clinical use. Referring first to FIG. 6, the catheter 22 is fitted over the guidewire 26 and forwards along and along the tissue tract until the forward end 28 of the catheter enters the blood vessel 30. It is slipped in. The catheter 22 is advanced forward until the blood vessel inlet port 34 enters the blood vessel, and blood is seen flowing from the blood return port 44 upon entering the blood vessel. The advancement of the catheter is stopped, and then the balloon 40 is inflated as shown in FIG. 7 by applying fluid pressure at the port 46. Due to the inflation of the balloon, the ring occluder 10 expands elastically. Once fully expanded, the catheter 22 is advanced forward as shown in FIG. In doing so, the shoulder 40c of the balloon 40 presses against the ring occluder 10, thereby penetrating the tissue and arterial wall where the branches 14 overlap. Catheter 22 is advanced with considerable resistance until further advancement is prevented. This indicates the correct position of the ring occluder 10. The balloon 40 is then fully deflated by venting through the port 46, resulting in some elastic contraction of the ring occluder 10 around the catheter 22, as shown in FIG. Once fully contracted and the guidewire 26 and catheter 22 are removed from the tissue tract and puncture hole 32, the ring occluder 10 is elastically contracted to its initial state, thereby pulling the edges of the puncture hole 32 together. Perform hemostasis. The closed ring occluder 10 remains positioned around the puncture hole of the artery as shown in FIG.

  Although the ring 12 or 12 'is shown as circular according to the above description and the balloon 40 is shown as being circularly symmetric about the catheter 22, the ring need not be circular and the cross section of the balloon The balloon may have any closed loop shape, and the balloon cross section may also vary. The term “ring” should be interpreted accordingly.

  FIGS. 11-13 show a modified embodiment of the catheter delivery device for the ring occluder 10 or 10 ′. A mechanical dilator is used in place of the balloon 40 used in the previous embodiment, and all other features of the previous embodiment are otherwise present in this embodiment. Good. The mechanical dilator has an oversleeve 50 applied to the catheter 22. FIG. 11A shows a cross-sectional view of the catheter in the vicinity of the over sleeve 50. The catheter has a longitudinal guidewire bore 24 and a blood return bore 38 as described above, and the sleeve 50 appears to coaxially surround the catheter body. The front end 52 of the sleeve is fixed to the outer surface of the catheter, and the rear end 53 of the sleeve 50 is slidable on the catheter 22. The section of the sleeve 50 located between the ends to which the occluder is attached in use is slit longitudinally to form a series of splines 54. Each spline 54 has four hinge locations 54a, 54b, 54c, 54d, the hinge locations 54a, 54d are located at the front and rear ends of the spline, and the hinge locations 54b, 54c are between them. Is located. The two intermediate hinge locations 54b, 54c are approximately aligned with the upper and lower edges of the section of the expandable ring 12 of the occluder 10 as shown in FIG.

  In the non-expanded state as shown in FIG. 13A, the spline 54 is positioned flush with the catheter. When the rear end 53 of the sleeve 50 is slid along the catheter 22 toward the fixed front end 52, the splines 54 are pushed radially outward relative to each other as shown in FIG. 10 expands elastically and simultaneously the occluder advances forward. With continued advancement of the posterior end 53 of the sleeve, the splines collapse inward from each other and stick to the catheter, thus releasing the occluder 10 from the splined section.

  In clinical use, the catheter 22 was slid along and over the guide wire 26 as shown in FIG. 14 so that a blood signal was finally received at the port 44 and thus the correct positioning was achieved. Will come to understand. At this point, the posterior end 53 of the sleeve 50 is advanced, whereby the occluder 10 is elastically expanded and advanced simultaneously to pierce the artery wall 30 (FIG. 15 (a)). Further advancement of the posterior end 53 of the sleeve causes the sleeve to release the occluder 10 (FIG. 15 (b)), thus allowing the catheter and guidewire to be withdrawn from the puncture hole 32 so that the occluder 10 is Fully contracted, the puncture hole can be closed (FIG. 15 (c)).

  The present invention is not limited to the embodiments described herein, and these embodiments can be modified or modified without departing from the scope of the present invention. be able to.

1 is a perspective view showing an embodiment of a ring occluder of the present invention in both an unexpanded state and an expanded state. FIG. It is a perspective view which shows the ring occluder as 2nd Embodiment in the non-expanded state and an expanded state. FIG. 3 is a plan view of a first embodiment of a catheter delivery device for the ring occluder of FIG. 1 or FIG. 2. FIG. 4 is an enlarged view of the delivery device of FIG. 3 near a ring occluder and an inflatable balloon. FIG. 4 is a cross-sectional view of the catheter taken along plane AA in FIG. 3. FIG. 6 shows one of a series of steps of a catheter delivery device in use. FIG. 6 shows one of a series of steps of a catheter delivery device in use. FIG. 6 shows one of a series of steps of a catheter delivery device in use. FIG. 6 shows one of a series of steps of a catheter delivery device in use. FIG. 6 shows one of a series of steps of a catheter delivery device in use. It is a perspective view which shows 2nd Embodiment of a catheter delivery apparatus in an unexpanded state. FIG. 13 is a cross-sectional view of a second embodiment of the catheter taken on plane AA of FIG. FIG. 12 is an elevational view of the catheter delivery device shown in FIG. 11. It is an elevation view which shows the ring occluder deployment means (dilator) of 2nd Embodiment of a catheter delivery apparatus in the initial rest position. FIG. 14 is an elevational view showing the dilator of FIG. 13 (a) in its intermediate front and fully expanded states. FIG. 14 is an elevational view showing the dilator of FIG. 13 (a) in its fully forward and collapsed state. FIG. 6 shows one of a series of steps of a second embodiment of a catheter delivery device in use. FIG. 6 shows one of a series of steps of a second embodiment of a catheter delivery device in use.

Claims (12)

A device for closing a puncture hole in a blood vessel, with an elongate body with a forward end insertable into the blood vessel through the puncture hole, and behind the front end for receiving and expanding the clip circumferentially A clip expander positioned on the body, the clip having a resiliently expandable perimeter and a plurality of barbed branches extending at least approximately in the same direction from one edge of the ring The clip expander receives the clip with its ring surrounding the dilator and its branch projecting distally from the clip dilator toward the front end of the body The clip dilator is located proximal to the distal tip of the branch, the clip dilator is operable to elastically expand around the ring, and the clip dilator The branch is around the hole It can move forward in its expanded state to puncture tissue, after which the clip dilator can be actuated to release the clip and allow the body and clip dilator to be removed from the ring Equipment. The clip expander has an inflatable enclosure that surrounds the body, the enclosure being operable to expand the ring by introducing fluid into the enclosure under pressure, and releasing the clip by withdrawing the fluid. The device of claim 1 , wherein the device is operable. The apparatus of claim 2 , wherein the fluid is introduced into the enclosure via a longitudinal bore provided in the body. The enclosure has a shoulder that is located behind the ring when inflated, and is configured to allow the forward movement of the body to push the clip forward into the tissue around the hole. The apparatus according to claim 2 or 3 , characterized in that The clip dilator has a sleeve surrounding the body, the sleeve having one end secured to the body, and the section of the sleeve located intermediate the end of the sleeve forms a plurality of splines. A slit is formed in the longitudinal direction, and the splines are pushed outward from each other by sliding the other end of the sleeve along the body toward the fixed end of the sleeve, The apparatus of claim 1 wherein the clip is attached to a splined section of the sleeve. Spline, the spline is moved outwardly from one another to expand the ring, claim splines also characterized in that it is hinged so as to advance the clip towards the front end of the body 5 The device described. After the clip is advanced, when the other end of the sleeve is further advanced toward the fixed end, the splines move inward from each other to release the clip. The apparatus of claim 6 . 8. A device according to any one of the preceding claims , wherein the body has a longitudinal bore at the puncture hole for slidably receiving a pre-positioned guide wire. 9. A device according to any one of the preceding claims , wherein the body has a longitudinal bore that serves as a blood return channel. 10. A device according to any one of the preceding claims, characterized in that the branches converge slightly towards the center of the ring. The device according to claim 1, wherein the ring is sinusoidal. The ring is comprised of a plurality of elongate segments each with a longitudinal central slit, the segments being arranged side by side around the ring with their longitudinal axes substantially parallel to each other, each The device according to claim 1, wherein the device is joined to the next segment by a relatively narrow constriction.

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